FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20E DEFIBRILLATOR/MONITOR
MDR report key: 1112529
·
Received August 11, 2008
Report
- Report Number
- 3015876-2008-00910
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- April 29, 2008
- Report Date
- May 7, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K073089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON AC POWER. THE POWER SUPPLY MODULE WILL BE REPLACED AND THEN THE DEVICE RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE POWER SUPPLY WAS FAULTY. A FAILURE OF THE DEVICE POWER SUPPLY MAY RESULT IN THE DEVICE FAILING TO OPERATE ON EITHER AC POWER, BATTERY POWER, OR BOTH. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20E DEFIBRILLATOR/MONITOR | MKJ | PHYSIO-CONTROL, INC. | 20E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |